Hemostasis valves are well-known, being currently used for example in arterial catheter introducers, which are used with catheters for performing percutaneous transluminal coronary angioplasty (PTCA), as well as catheters for angiographic procedures, for example where x-ray contrast fluid is inserted through a catheter into the coronary artery. The hemostasis valve is typically used to prevent the leakage of blood out of or around dilatation and other catheters which particularly extend into an artery, to prevent the reverse seepage of blood out of the patient into the operating field. Typically, hemostasis valves are conventionally positioned at the proximal ends of catheter introducers, which are used to facilitate the entrance of catheters into an artery or other blood vessel.
Numerous types of hemostasis valves are known. By way of example, see Stevens U.S. Pat. No. 4,000,739, Matsumoto, et al. U.S. Pat. No. 4,610,655, Weinstein U.S. Pat. No. 4,626,245, and Hillstead U.S. Pat. No. 4,798,594.
While many of the commercially available hemostasis valves are fairly tolerant of various diameters of probes and catheters passing through them, to permit good sealing over a relatively large diameter range, all of the currently available valves have significant limitations as to the variation in catheter diameter which can pass through the valve without damaging it, and while providing good sealing.
In accordance with this invention, a valve is provided for elongated members such as probes and catheters in which the same valve can provide sealing against a greatly increased range of probe or catheter diameters. Additionally, while difficulties in passing a probe or catheter through prior valves have been noted, the valve of this invention, which may be pressure-actuated, can provide a wide aperture for insertion of a probe or catheter, and then can provide a sealing pressure against such probe or catheter of any desired amount, limited primarily by the strength of the materials involved. Also, the pressure-actuated valve of this invention may be positively closed for sealing at any desired pressure, to provide any desired level of sealing against high pressures when a catheter or probe is not penetrating therethrough.
Thus, the pressure-actuated valves of this invention exhibit great versatility and effectiveness, particularly in their preferred use as a hemostasis valve on a catheter sheath introducer or any other desired medical device. Additionally, the valve of this invention may be used in any other desired non-medical application.